Quality Assurance Specialist
2 days ago
Job Summary:
The Quality Assurance Specialist will be responsible for ensuring that all Taro products meet the company and cGMP requirements before release for sale, manufacture, or packaging. This includes reviewing laboratory-related documents, accuracy of data entries, and contributing to reports and performance metrics.
Key Responsibilities:
- Review laboratory-related documents to ensure compliance with Taro and GMP requirements
- Verify accuracy of data entries in BPCS and/or LIMS
- Contribute to reports and performance metrics
- Automate job functions to achieve efficiency improvements
- Work with other departments to build quality into processes and systems
- Complete GMP documentation correctly and in a timely manner
- Complete training assignments and maintain personal training records
- Participate in and/or lead Non-Conformance Investigations
- Complete Corrective and Preventive Actions (CAPA's)
- Initiate and follow through with actions required to close Change Controls
- Participate in Internal, Customer, and Regulatory Audits
- Assist personnel with documentation issues and provide coaching and guidance to the Quality Control team
- May be required to deliver technical training programs
- Participate in activities supporting Laboratory Investigations
- Provide support for Regulatory Inspections
- Identify and implement key process improvements to enhance systems, gain site efficiencies, and elevate GMP requirements
Requirements:
- B. Sc. (Chemistry or Microbiology) or equivalent experience required
- Minimum 5 years experience with quality control laboratory background in pharmaceutical industry
- Quality Assurance and audit background in pharmaceutical industry would be an asset
- Proficient knowledge of applicable instruments (HPLC, GC experience preferred)
- Multi-tasking ability
Working Conditions:
- Generally pleasant conditions, with occasional exposure to higher than normal noise levels
- Desk work with a mixture of standing and walking, and some light lifting
- Ability to work under stressful conditions and prioritize workload
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